Docket Number:
FDA-2015-D-1211
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

This revised guidance document provides you, blood establishments that collect blood or blood components, including Source Plasma, with FDA’s revised donor deferral recommendations for individuals with increased risk for transmitting human immunodeficiency virus (HIV) infection.  We (FDA) are also recommending that you make corresponding revisions to your donor educational materials, donor history questionnaires and accompanying materials, along with revisions to your donor requalification and product management procedures.  This guidance also incorporates certain other recommendations related to donor educational materials.  This updates the guidance of the same title dated April 2020.  The April 2020 guidance superseded the December 2015 guidance of the same title (Notice of Availability, 80 FR 79913 (December 17, 2015)).  The recommendations contained in this guidance apply to the collection of blood and blood components, including Source Plasma.

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